MAUDE Adverse Event Report: DENTSPLY LLC PALODENT V3 UNIV 2 RING REFIL; INSTRUMENTS, DENTAL HAND

Catalog Number	659760V
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such.This event, therefore, is reportable per 21cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
Event or Problem Description
In this event it is reported that a palodent v3 univ 2 ring refil broke during use.No injury occurred.
Additional Manufacturer Narrative
Returned product 1 v3 universal palodent ring (new and improved design v5) with 1 of the tynes broken off/missing from one side of the ring.Overmolding date codes ¿g¿ for july and ¿n¿ for 2022.Returned product does not meet specifications, final packaging product retains are not kept as per normal procedure.Ring over-molding retain from item# 759870 batches 05625020 & 05625021 were pulled, reviewed, and deemed acceptable as per 0290-ip-7.5-60-58 and meet all form/fit/function.Dhr for item# 659760v batch# 05758767 has been pulled, reviewed, and attached to this case.Dhr review did not indicate any production issues while packaging/labeling the palodent v3 univ 2 ring refil.Work order 05758767 is the packaging work order which utilized 2 over-molding of the springs to rings production work orders/runs item# 759870 batches 05625020 (v5 ring universal ¿ palodent; mfg 07-2022) & 05625021 (v5 ring universal ¿ palodent; mfg 07-2022).The over-molding work orders is only to mold the tynes to the spring.Dhr review for both overmolding work orders did not indicate any production issues, nor any comments noted with all inspections performed and deemed acceptable by the operator(s) and quality as per 0290-ip-7.5-60-58.

• Brand Name: PALODENT V3 UNIV 2 RING REFIL
• Common Device Name: INSTRUMENTS, DENTAL HAND
• Manufacturer (Section D): DENTSPLY LLC; 38 west clarke avenue; milford DE 19963
• Manufacturer (Section G): DENTSPLY LLC; 38 west clarke avenue; milford DE 19963
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 19817859
• Report Number: 2515379-2024-00034
• Device Sequence Number: 8891724
• Product Code: DZN
• UDI-Device Identifier: D002659760V1
• UDI-Public: D002659760V1
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 659760V
• Device Lot Number: 05758767
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/24/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown